Assessing Heterogeneity of Treatment Effects: Are Authors Misinterpreting Their Results?

Erik Fernández y García · Hien Nguyen · Naihua Duan · Nicole B. Gabler · Richard L. Kravitz

23 citations0/0 files storedHealth Services Research

No readable copy stored yet — this record is metadata only.

No open-access location is known for this record yet.

Literature note Cite in a project Citation map

Meta-analysis and systematic reviews Statistical Methods in Clinical Trials Advanced Causal Inference Techniques

Abstract

OBJECTIVE: To determine whether investigations of heterogeneity of treatment effects (HTE) in randomized-controlled trials (RCTs) are prespecified and whether authors' interpretations of their analyses are consistent with the objective evidence. DATA SOURCES/STUDY SETTING: Trials published in Annals of Internal Medicine, British Medical Journal, Journal of the American Medical Association, Lancet, and New England Journal of Medicine in 1994, 1999, and 2004. STUDY DESIGN: We reviewed 87 RCTs that reported formal tests for statistical interaction or heterogeneity (HTE analyses), derived from a probability sample of 541 articles. DATA COLLECTION/EXTRACTION: We recorded reasons for performing HTE analysis; an objective classification of evidence for HTE (termed "clinicostatistical divergence" [CSD]); and authors' interpretations of findings. Authors' interpretations, compared with CSD, were coded as understated, overstated, or adequately stated. PRINCIPLE FINDINGS: Fifty-three RCTs (61 percent) claimed prespecified covariates for HTE analyses. Trials showed strong (6), moderate (11), weak (25), or negligible (16) evidence for CSD (29 could not be classified due to inadequate information). Authors stated that evidence for HTE was sufficient to support differential treatment in subgroups (10); warranted more research (31); was absent (21); or provided no interpretation (25). HTE was overstated in 22 trials, adequately stated in 57 trials, and understated in 8 trials. CONCLUSIONS: Inconsistencies in performance and reporting may limit the potential of HTE analysis as a tool for identifying HTE and individualizing care in diverse populations. Recommendations for future studies on the reporting and interpretation of HTE analyses are provided.

Paper brief

Loading…

Cite this work

Citation unavailable for this work.

BibTeX RIS CSL-JSON

No public copy is stored for this record, so only the metadata is cited.

Citations in this library

Citation map →

Stored only when both papers are in the corpus — 23 citations exist upstream.

References

2001The Revised CONSORT Statement for Reporting Randomized Trials: Explanation and Elaboration 2010Initial National Priorities for Comparative Effectiveness Research 2006Moderators of Treatment Outcomes 2005Principles for international registration of protocol information and results from human trials of health related interventions: Ottawa statement (part 1)2009Does Comparative-Effectiveness Research Threaten Personalized Medicine?1986Which Medical Journals Have the Greatest Impact?2007Life and times of the impact factor: retrospective analysis of trends for seven medical journals (1994-2005) and their Editors' views 2009Comparative-Effectiveness Research — Implications of the Federal Coordinating Council's Report

Cited by

2017Social Relationships and Salivary Telomere Length Among Middle-Aged and Older African American and White Adults 2017An approach to addressing subpopulation considerations in systematic reviews: the experience of reviewers supporting the U.S. Preventive Services Task Force

Explore the map →

Papers that cite the same references — the relational fallback while embeddings are still backfilling.

Imported from OpenAlex (CC0) — nothing here is generated.